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减少中心受累糖尿病性黄斑水肿的发生

2016年8月25日 更新者：Chromaderm, Inc.
这项研究的目的是确定 ruboxistaurin 是否可以帮助减缓糖尿病患者称为黄斑水肿的眼病的恶化。

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

731

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 丹麦
      • Aarhus、丹麦、8000
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Glostrup、丹麦、2600
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  • 俄罗斯联邦
      • Moscow、俄罗斯联邦、117036
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Saint Petersburg、俄罗斯联邦、195176
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • 加拿大
    • British Columbia
      • Vancouver、British Columbia、加拿大、V5Z 4E1
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Nova Scotia
      • Halifax、Nova Scotia、加拿大、B3H 2Y9
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Ontario
      • London、Ontario、加拿大、N6A 4G5
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Ottawa、Ontario、加拿大、K1H 1A2
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      • Toronto、Ontario、加拿大、M4N 3M5
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    • Quebec
      • Montreal、Quebec、加拿大、H2L 4M1
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  • 印度
      • Chennai、印度、600006
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      • Hyderabaad、印度、500034
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      • New Delhi、印度、110029
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  • 台湾
      • Tao-Yuan、台湾、333
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • 墨西哥
      • Mexico City、墨西哥、04030
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • 巴西
      • Curitiba、巴西、80420-170
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Goiania、巴西、74210-010
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Sao Paulo、巴西、05403-010
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • 德国
      • Leipzig、德国、04103
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Munster、德国、48145
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Sulzbach、德国、66280
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Ulm、德国、D-89075
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  • 意大利
      • Milano、意大利、20132
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Udine、意大利、33100
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  • 法国
      • Bordeaux、法国、33076
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Nantes、法国、44093
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      • Paris、法国、75010
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  • 波兰
      • Bydgoszcz、波兰、85-822
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Katowice、波兰、40-044
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Lublin、波兰、20-081
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Poznan、波兰、61-696
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • 澳大利亚
    • New South Wales
      • Parramatta、New South Wales、澳大利亚、2150
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Sydney、New South Wales、澳大利亚、2000
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Westmead、New South Wales、澳大利亚、2145
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • South Australia
      • Woodville、South Australia、澳大利亚、5011
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Western Australia
      • Nedlands、Western Australia、澳大利亚、6009
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • 美国
    • California
      • Artesia、California、美国、90701
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Palm Springs、California、美国、92262
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Poway、California、美国、92064
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Walnut Creek、California、美国、94598
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Colorado
      • Denver、Colorado、美国、80262
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Connecticut
      • New London、Connecticut、美国、06320
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Florida
      • Jacksonville、Florida、美国、32204
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Sunrise、Florida、美国、33351
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Georgia
      • Augusta、Georgia、美国、30909
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Idaho
      • Idaho Falls、Idaho、美国、83404
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Illinois
      • Wheaton、Illinois、美国、60187
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Iowa
      • Iowa City、Iowa、美国、52242
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Maryland
      • Baltimore、Maryland、美国、21287
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Massachusetts
      • Boston、Massachusetts、美国、02215
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Peabody、Massachusetts、美国、01960
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Michigan
      • Grand Rapids、Michigan、美国、49525
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Missouri
      • Columbia、Missouri、美国、65212
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Independence、Missouri、美国、64055
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • New Jersey
      • New Brunswick、New Jersey、美国、08901
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Teaneck、New Jersey、美国、07666
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • New Mexico
      • Albuquerque、New Mexico、美国、87102
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • New York
      • Rockville Center、New York、美国、11570
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • North Carolina
      • Charlotte、North Carolina、美国、28210
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • North Dakota
      • Fargo、North Dakota、美国、58104
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Ohio
      • Beachwood、Ohio、美国、44122
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Cincinnati、Ohio、美国、45242
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Cleveland、Ohio、美国、44195
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Oklahoma
      • Oklahoma City、Oklahoma、美国、73104
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Pennsylvania
      • Hershey、Pennsylvania、美国、17033
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Pittsburgh、Pennsylvania、美国、15213
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • South Dakota
      • Rapid City、South Dakota、美国、57701
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Texas
      • Arlington、Texas、美国、76012
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Dallas、Texas、美国、75231
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Houston、Texas、美国、77030
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Utah
      • Ogden、Utah、美国、84403
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Salt Lake City、Utah、美国、84107
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • 英国
      • Bristol、英国、BS1 2LX
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • London、英国、EC1V 2PD
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Merseyside
      • Liverpool、Merseyside、英国、L7 8XP
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Scotland
      • Aberdeen、Scotland、英国、AB25 2ZN
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • West Midlands
      • Birmingham、West Midlands、英国、B9 5SS
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • 荷兰
      • Amsterdam、荷兰、1081 HV
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Rotterdam、荷兰、3011 BH
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • 葡萄牙
      • Coimbra、葡萄牙、3000-548
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • 西班牙
      • Alicante、西班牙、03015
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Barcelona、西班牙、08022
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Madrid、西班牙、28002
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Valladolid、西班牙、47005
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

纳入标准：

  • 1 型或 2 型糖尿病
  • 18岁或以上
  • 无临床意义的糖尿病性黄斑水肿
  • 研究眼轻度至中度糖尿病视网膜病变，研究眼玻璃体出血
  • 相对良好的视力（20/30 或更好）

排除标准：

  • 研究眼的手术或激光治疗
  • 研究眼中的青光眼
  • 糖化血红蛋白 (HbA1c) 大于 11%，或收缩压大于 170 毫米汞柱 (mmHg)
  • 肝病、透析或肾移植

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：鲁博西妥林
32 毫克 (mg) 每天一次 (QD) 口服长达 36 个月
药品：鲁博西妥林
32 毫克每天一次 (QD) 口服长达 36 个月
其他名称：
  • LY333531
  • 阿克桑特
安慰剂比较：安慰剂
QD 口服长达 36 个月
药品：安慰剂
QD 口服长达 36 个月

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
糖尿病性黄斑水肿 (DME) 累及黄斑中心的平均持续时间
大体时间：6 个月至 36 个月
黄斑中心受累的持续时间 当主要研究结果（DME 受累于黄斑中心，由立体眼底照片的中央分级确定）在一次就诊时被确定，参与者被认为在相邻的特定时间长度内有明确的中心受累访问。 计算中心参与的总持续时间。 平均持续时间是中心参与的总持续时间除以参与者总数。 总结了参与者的持续时间，显示了两个治疗组中心参与的总月数。
6 个月至 36 个月
糖尿病视网膜病变 (DR) 研究眼睛中持续中度视力丧失 (SMVL) 的发生
大体时间：基线，36 个月
SMVL 的发生被定义为在参与的最后 6 个月中，任何 DR 研究眼睛的最佳矫正早期治疗糖尿病视网膜病变研究 (ETDRS) 视力 (VA) 相对于基线下降≥15 个字母。 ETDRS VA：参与者从图表顶部开始，每行包含 5 个字母，然后向下阅读图表，直到到达一行中至少 3 个字母无法阅读的行。 参与者根据可以正确识别的字母数量进行评分。 正确识别的字母数量越多代表视力越好。
基线，36 个月

次要结果测量

结果测量
措施说明
大体时间
36 个月时早期治疗糖尿病视网膜病变研究 (ETDRS) 视力 (VA) 图表显示视力相对于基线的变化
大体时间：基线，36 个月
ETDRS VA：参与者从图表顶部开始，每行包含 5 个字母，然后向下阅读图表，直到到达一行中至少 3 个字母无法阅读的行。 参与者根据可以正确识别的字母数量进行评分。 正确识别的字母数量越多代表视力越好。 根据糖尿病视网膜病变 (DR) 眼的数量报告结果。
基线，36 个月
焦点/网格光凝的首次出现
大体时间：通过 36 个月的基线
无论糖尿病性黄斑水肿 (DME) 距黄斑中心的距离如何，首次出现局灶性/网格光凝。
通过 36 个月的基线
Pelli-Robson 对比敏感度基线的变化
大体时间：基线，36 个月
Pelli-Robson 图表从左到右 + 从上到下阅读。 每行有 2 组，每组 3 个字母。 每组中的字母具有相同的对比度。 每个连续组中的对比度都小于前一组。 参与者从对比度最高的字母开始阅读，一直读到 1 组中有 2 或 3 个字母被错误命名。 在以全对比度显示所有字母的键上得分，给出对应于每个组的对数对比敏感度。 分数由前一组决定（最后一组正确命名了 2 或 3 个字母）。 根据 DR 眼睛的数量报告结果。
基线，36 个月
七场立体眼底摄影对非增殖性糖尿病性视网膜病变 (DR) 的进展
大体时间：通过 36 个月的基线
参与者被分类为在 36 个月的访问中经历了 DR 进展或没有进展。 对于双眼在基线时低于增殖性糖尿病视网膜病变 (PDR) 的参与者，在 ETDRS 视网膜病变严重程度个人量表上的 DR = 3 级进展，或者对于在基线时 1 只眼睛低于 PDR 的参与者，在 ETDRS 视网膜病变严重程度眼量表上的 2 级进展或应用全视网膜激光治疗。 参与者在基线时被分配到 ETDRS 人眼或单眼视网膜病变严重程度量表；无进展/进展的确定取决于量表。
通过 36 个月的基线
估计肾小球滤过率相对于基线的变化
大体时间：基线，36 个月
用于估计肾小球滤过率 (eGFR) 测定的肾脏疾病饮食改良 (MDRD) 研究公式为：eGFR = 170 X（血清肌酐浓度 [mg/dL]）-0.999 X（年龄[岁]）-0.176 X（如果参与者是女性则为 0.762）X（如果参与者是黑人则为 1.180）X（血清尿素氮浓度 [mg/dL]）-0.170 X（血清白蛋白浓度[克（g）/dL]）+0.318。
基线，36 个月
白蛋白/肌酐比值在终点处相对于基线的变化
大体时间：36个月
36个月
36 个月时国家眼科研究所视觉功能问卷 (NEI VFQ-25) 的视觉功能终点相对于基线的变化
大体时间：36个月
25 个视觉目标问题代表 11 个视觉相关结构和一个 1 项一般健康评级问题。 衡量视觉障碍和视觉症状对情绪健康和社会功能等一般健康领域以及与日常视觉功能相关的任务导向领域的影响。 每个项目都转换为 0 到 100 的等级，因此较高的分数表示更好的功能。
36个月
出现不良事件的参与者人数
大体时间：通过 36 个月的基线
严重不良事件 (SAE) 和所有其他非严重不良事件 (AE) 的摘要位于已报告的不良事件模块中。
通过 36 个月的基线

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Chromaderm, Inc.

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2004年2月1日

初级完成 (实际的)

2010年4月1日

研究完成 (实际的)

2010年4月1日

研究注册日期

首次提交

2004年8月26日

首先提交符合 QC 标准的

2004年8月30日

首次发布 (估计)

2004年8月31日

研究记录更新

最后更新发布 (估计)

2016年10月6日

上次提交的符合 QC 标准的更新

2016年8月25日

最后验证

2016年8月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 8211
  • B7A-MC-MBDL (其他标识符：Eli Lilly and Company)

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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